Put your REMS in inVentiv hands - inVentiv Health

Put your REMS in
inVentiv hands

Step 1
Bring us your challenge
If you’re preparing to execute a REMS (Risk
Evaluation and Mitigation Strategy), partner
with inVentiv Health. inVentiv has the experience and expertise e to
not just manage your
REMS, but to make it part of a plan for releasing your brand’s full potential.
inVentiv is the only company in the healthcare industry with a complete range of
commercialization services for every stage of a product’s life cycle. This gives us a
unique ability to provide a broader perspective on the challenges you face—and the
opportunities. At inVentiv, we build multidisciplinary teams across 5 divisions—Advance
Insights, Clinical, Communications, Selling Solutions, and Patient Outcomes. We then
coordinate team insights through a single point of contact for effi cient workfl ow. The
result: innovative and manageable solutions for clients large and small—solutions that
accelerate your vision for your brand while creating better outcomes for patients.
Because we see the big picture, we are ideally suited to assist with complex regulatory
challenges like a REMS. Over the years our people have created solutions for products
with boxed warnings, risk management action plans (RiskMAPs), and REMS requirements.
So, whether it’s a turnkey program or something more tailored, inVentiv has
the experience and broad capabilities you need. We invite you to read more about how
inVentiv can make your REMS come together with brand success.

Step 2
Discover
all we offer
A REMS touches
every part of your organization. ation. inVentiv Health can manage every
part of your REMS.
Strategy teg
development
Whether you have a compound in early clinical development or a fully commercialized brand,
making the right moves early in the REMS process can determine future success. So, even
before your compound receives a REMS mandate, inVentiv can guide you. We’ll analyze the
risk scenario and outline the likely scope of your requirements. From there, we can develop an
optimal FDA negotiation strategy. inVentiv knows that if you set your brand on the right course
early, it’s less likely to lose its way later on.
Program design
Rely on the expertise of inVentiv to design your REMS right, with properly scaled, well-targeted
tools to help ensure safe and appropriate use. If you need a comprehensive plan, our broad
capabilities can coordinate seamlessly across clinical, regulatory, and marketing. If the need
is more limited, we provide focused expertise that complements your larger program and
existing in-house resources. Communication plans, patient and prescriber registries, reimbursement
programs, performance-linked access systems, and distribution through specialty
pharmacies—whatever the need, inVentiv can design a solution.
Implementation
The way we see it, a well-implemented REMS program supports your larger brand goals. Minimal
burdens on stakeholders, clear communication, and streamlined access can serve both
to mitigate product risks and deepen brand connections. At inVentiv, we’ve mastered the arts
of risk education and communication, database development and management, and pharmacovigilance.
After executing programs for scores of brands with significant safety risks, we’re
comfortable working in highly regulated spaces, which means you’ll be comfortable, too.
Evaluation and reporting
While failure to meet REMS objectives can lead to severe consequences, effective
execution may result in early release from monitoring requirements. To this high-stakes
endeavor inVentiv brings a variety of resources to meet your needs, including analytics,
consulting services, logistics, and distribution. We can execute stakeholder surveys that
measure understanding of risks and processes. We can manage data on adverse events and
other outcome metrics for you. We can even design and prepare your reporting packages.
It’s all part of helping your REMS be a well-managed component of your brand’s success.

Step 3
Customize
your solution
The solutions inVentiv Health offers are as varied as the pharma landscape a itself.
But we’ll
el always provide answers that t
meet objectives, minimize imiz
burdens, and
streamline access. ce Here are some of the ways we do it.
Sales force optimization
Should your sales force have minimal involvement in REMS implementation, or should it be a
key part of the job Should you bring in certified nurse educators to conduct risk education
To help you answer these kinds of questions, inVentiv brings expert analysis that considers the
scope of the plan, the makeup of your force, and the number of medical science professionals
in it. We can analyze different scenarios for you to find the one that best supports your
REMS—and your brand.
Branding
Creating a branded identity for your REMS can enhance your overall product offering.
Done well, a branded REMS adds credibility, aids memory, strengthens communication, and
provides the basis for a sustainable competitive advantage. inVentiv has a well-established
record of success with sensitive branding challenges, which means we can help your REMS
establish a positive connection with stakeholders.
Pharmacovigilance
With inVentiv, you can choose from a suite of end-to-end pharmacovigilance services to
meet your needs. We offer everything from case intake, medical coding, and validated
signal detection to case narrative preparation, medical review, and regulatory submission.
We can work with your database or you can use our Argus system, built for part 11
compliance and completely secure. We can even provide you with real-time reporting
tools. We take a proactive approach that gives you vigilance outside the reporting cycle,
for a continual assessment of your product’s safety profi le.
A single point of service
Even the smallest REMS-related task can require coordination between functional areas.
That’s why, big or small, your REMS project is overseen by a single cross-functional contact,
your inVentiv project director. This individual is there whenever needed, streamlining communication
and workflow, developing timelines, coordinating handoffs, and managing execution
and fi nal delivery. Every step of the way, your inVentiv project director ensures that your
project is completed on time, on budget, and with maximum effi ciency.

Step 4
Let
One partner r gets you to all your goals
Whatever er your rR
REMS challenge, the experience and expertise e of inVentiv Health can help
you meet et it. Whether it’s a comprehensive program or
a small task, we’ll work with you to
find the solution that fulfills your mandate efficiently and responsibly, helping your brand
thrive while promoting better patient outcomes. Through a single point of contact, we’ll
minimize the burden to your customers and your own organization and maximize the
opportunities for your brand. So put your REMS in inVentiv hands: we’ll help you achieve
an unmitigated success.
your brand fly

The inVentiv REMS: risk minimization miz that helps
release your brand’s maximum potential
Broad experience with REMS (Risk
Evaluation and Mitigation Strategies)
and other regulatory challenges
A complete suite of REMS-related services
A single point of service to get you to
all your goals
Start achieving unmitigated success with an inVentiv REMS.
Contact Dan Bobear at inVentiv Health today.
Dan Bobear
518.226.4116
dbobear@inventivhealth.com
Or visit us at inventivhealth.com/REMS.